Senior Engineer, Quality Engineering

The Position

This position within the Quality Assurance department will support ongoing programs for commercialization at Arrowhead.  A key function of the position will involve providing leadership and guidance in principles of qualification, cleaning validation, process validation and continued process verification (CPV) in support of commercialization activities at Arrowhead.

Generally, the position will support continued development and maintenance of quality systems supporting Good Manufacturing Practices (GMP) within the organization. Functions of this position will include serving as the Quality Assurance subject matter expert in qualification/validation, cross-functional interaction with internal departments to establish and/or update associated procedures/processes, review/approval of product lifecycle and validation documentation, performing validation assessment of changes and deviations for GMP systems and processes. 

Responsibilities

• Serve as the Quality Assurance subject matter expert on qualification, cleaning validation, process validation and CPV. This includes providing guidance, review, and approval of activities such as system requirements engineering, process design, risk assessments, and supporting validation documentation. For cleaning and process validation, provide support in establishment of supporting documentation and templates including risk assessments (for product-contact equipment, process, materials, and CQAs) and parameter classification.
• Draft, review, and approve procedures in support of quality systems for qualification and validation.
• Serve as a resource to mentor Quality Assurance members in Quality Engineering functions (e.g., department procedures, audits, cleaning validation, equipment qualification, process validation, validation assessments, CPV, etc.).
• Work with cross-functional teams in the review and approval of internal and vendor-generated data and documentation in support of validation, qualification, and commissioning activities.
• Provide support for the issuance, review, tracking, and approval of internal deviations, change controls, and CAPAs as related to validation activities and assessments.
• Support the development and implementation of periodic reviews for validated systems/processes including establishment of CPV procedures for commercial manufacturing.
• Provide secondary review of registration batches to evaluate and assess any systemic issues.
• Prepare documentation and provide support for internal and external audits.
• Other duties, consistent with the position, as assigned.

Requirements

• A bachelor's degree, or higher, in a science field.
• Bachelor's degree with 15+ years of experience working within cGMP-regulated manufacturing, specifically in validation-related roles in manufacturing and/or quality.
• Working knowledge of GMP regulations (21CFR Part 210/211, EU Annex 11/15, ICH Q7, and 21CFR Part 11).
• Excellent attention to detail and organizational skills.
• Ability to multi-task and prioritize work tasks with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills
• Competent knowledge and ability to use Microsoft Word and Excel.

Preferred 

• Prior experience with the use of an electronic document management system in a regulated environment.